Kornimate/medical-research-clean huggingface dataset:
carbon ion followed by proton radiotherapy for prostate cancer with pelvic lymph nodes metastases

Conditions: Prostate Cancer

Summary: the present of clinically pelvic lymph node positive (cn1) represent one of the most important prognostic factors for recurrence and cancer-specific mortality of prostate cancer patients. approximately 12% of prostate cancer patients present with cn1 disease at the time of diagnosis. furthermore, with the advent of more sensitive advance diagnostic imaging techniques, such as psma pet/ct, the likelihood that pelvic nodes will be found earlier and more frequently. unfortunately, the optimal treatment for patients with cn1 still remains unclear. androgen deprivation therapy (adt) is the cornerstone of prostate cancer with pelvic lymph node metastasis. some retrospective and database studies have shown that addition of local radiotherapy (rt) to adt improve the treatment outcome. the 2022 nccn guideline recommend rt combined with 2 to 3 years adt in patients with initially diagnosed cn1 prostate cancer who have a life expectancy greater than 5 years.


Eligibility criteria:
inclusion criteria: * histologically proven initial diagnosis of adenocarcinoma of the prostate; * clinical stage t1-4 n0 m0; * prostatic assessment by multiparametric (mp) mri; * pelvic lymph node was assessed by psma pet/ct and mpmri; * no distant metastasis was proven by psma pet/ct; * patients may received neoadjuvant hormonal therapy; * 45≤ age ≤85; * adequate performance status (ecog 0-1); * no previous pelvic radiation therapy (rt); * no previous prostatectomy; * no previous invasive cancer (within 5 years before the prostate cancer diagnosis); * ability to understand character and individual consequences of the clinical trial; * written informed consent; exclusion criteria: * no pathologically confirmed adenocarcinoma of the prostate; * distant metastasis (m1); * previous pelvic radiotherapy; * previous prostatectomy;

Keywords: carbon ion proton prostate cancer pelvic lymph nodes metastases
archive prostate. observational study of patients who underwent radical prostatectomy surgery

Conditions: Prostate Cancer

Summary: this is a single-center, observational, prospective study on quality of life and disease status of patients who underwent radical prostatectomy. data related to clinical conditions (oncological, psychological, sexual and quality of life) of these patients are collected in a database.

a database was created with the intention of collecting data related to patients with diagnosis of prostate cancer who underwent radical prostatectomy. anamnesis, surgery, histological report and hospitalization data are collected for patients who underwent radical prostatectomy. each patient will be followed for 10 years from the date of radical prostatectomy surgery. each patient will receive a questionnaire before radical prostatectomy in order to evaluate the quality of life (urinary continence, erectile function and psycho-physical wellbeing). a follow up questionnaire will be collected after surgery in order to analyze the predictive factors of the disease, clinical progression and to obtain health benefits for the patients involved and for future patients with the same tipe of cancer, improving the scientific knowledge of the pathology and implementing new strategies for diagnosis and therapy and evaluating the epidemiologic changes of prostate cancer. tha data collected will be handles following the most strict good clinical practice (gcps) and privacy norms.

Eligibility criteria:
inclusion criteria: * patients with prostate cancer who underwent radical prostatectomy; * adult patients \> 18 years * ability to read and sign the informed consent exclusion criteria: * patients \< 18 years * mental or physical disability that may prevent the patient from satisfying the requirements of the protocol * inability to read and sign the informed consent
endoscopic characteristics of duodenal and ampullary lesions

Conditions: Duodenal Diseases

Summary: the purpose is to investigate whether polyps that look different at endoscopy, have formed via different mutations and have different risks of turning into cancer.

laterally spreading tumours (lsts), are polyps that have a lateral extension along the duodenal wall with minimal vertical growth. it has become evident over the last few years that rather than being a single entity requiring an accumulation of mutations, duodenal and ampullary cancer is in fact a heterogenous disease forming via multiple distinct genetic pathways. it is therefore hypothesised that different polyp types have different genetic abnormalities, and potentially form via distinct genetic pathways, although this theory has not been widely examined. this knowledge would be important in furthering our understanding of the development of cancer. there is accumulating evidence that genetic abnormalities may be a better predictor of cancer behaviour than histological grade. additionally, guidelines for endoscopy surveillance are currently a one size fits all approach that do not reflect the genetic heterogeneity of the disease and the knowledge that only 5% of polyps progress to cancer. genetic studies may assess future cancer risk to a person in polyps once removed and plan surveillance endoscopy frequency.

Eligibility criteria:
inclusion criteria: * intention to perform endoscopic mucosal resection * adenoma equal to or greater than 20mm * over 18 years of age * able to give informed consent to involvement in trial exclusion criteria: * pregnancy * lactation: currently breastfeeding * taken clopidogrel within 7 days * taken warfarin within 5 days * had full therapeutic dose unfractionated heparin within 6 hours * had full therapeutic dose low molecular weight heparin (lmwh) within 12 hours * known clotting disorder

Keywords: duodenal adenoma ampullary adenoma
safety and efficacy of i 0401 in the treatment of tibial plateau fractures requiring grafting

Conditions: Tibia Plateau Fractures

Summary: for certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. the void provoked by the compression of the bone is filled with an appropriate filling material and the fracture is fixated. i 0401 is a new bone graft substitute that has shown capacities to promote bone-healing. this study will test the safety and efficacy of i 0401 in the treatment of patients with tibial plateau fractures requiring grafting.


Eligibility criteria:
inclusion criteria: * radiological evidence of a tibial plateau fracture requiring grafting * females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening). exclusion criteria: * concomitant ipsilateral fractures of the limb other than the fracture of the tibial plateau. * active or past history of malignant tumor. * evidence of systemic or localized infection at time of surgery. * pregnant or lactating females.

Keywords: bone graft substitute promotion of bone healing
analgesia effects of intravenous ketamine after spinal anesthesia for non-elective cesarean section

Conditions: Non Elective Cesarean Section and Ketamine Analgesia

Summary: this randomized double blind study will be conducted in pregnant woman planned for non elective cesarean section under spinal anesthesia. ketamine group will receive intravenous 0.25 mg/kg and placebo group will receive same amount of normal saline after spinal anesthesia prior to skin incision. postoperative outcomes measures are total opioid consumption and pain scores for 24 hrs.


Eligibility criteria:
inclusion criteria: * • all women at term(\>or =37 weeks of gestation) * healthy * american society of anesthesiologists(asa) class1 and 2 * women undergoing non-elective caesarean section whose anesthetic plan is for spinal anesthesia with bupivacaine and fentanyl exclusion criteria: * • women with american society of anesthesiologist physical status\>2 * body mass index \>or =40 kg per square meter * height \<150 cm * any contraindication to the spinal anesthesia * history of substance abuse * history of hallucinations * chronic opioid therapy * chronic pain or on any pain medication currently * patient with maternal complications,like cardiovascular disease pre-eclampsia,diabetes,multiple gestation,known fetal abnormality * cases with severely compromised fetus where immediate administration of general anesthesia is required.
healthy eating and active living for diabetes: glycemic index

Conditions: Type 2 Diabetes

Summary: the main purpose of this study is to examine the effectiveness of enhanced gi-targeted nutrition education on dietary behaviour and intakes among adults with type 2 diabetes. sixty-six eligible participants will be randomized into two equal groups using a pragmatic randomized controlled trial design.

this study proposes to examine the effectiveness of enhanced gi-targeted nutrition education on dietary behaviour and intakes among adults with type 2 diabetes. adults with type 2 diabetes will take part in this study and will be randomly assigned to either the heald-gi program (intervention) or in usual care (control). to evaluate the effectiveness of the program, 66 eligible participants drawn from the alberta's caring for diabetes cohort will be randomized into two equal groups using a pragmatic randomized controlled trial design. the control will receive only standard printed copies of canada food guide and canadian diabetes association (cda) gi resources. the intervention group will receive additional gi concept information including gi values of foods, low gi recipes, menus, and application through websites with chat rooms, online videos, and print materials. these will be reinforced through email, text messaging/phone calls, and postal mail. gi knowledge and skill, self-efficacy, dietary intakes (using 3-day food record), anthropometry (body mass), and clinical measures (glycated hemoglobin a1c, systolic blood pressure), will be assessed at baseline and three months post-intervention. the primary outcome will be change in gi related dietary behaviour and intake measured using 3-day food records (baseline and 3 months). secondary outcomes include: 1) body mass, 2) glycemic control (hemoglobin a1c), 3) systolic blood pressure. significance: sufficient evidence is needed regarding the best approach for increasing uptake of current canadian diabetes association (cda) evidence-based recommendation to include low gi foods in daily meal planning as an effective dietary self-care practice for glycemic control among people with type 2 diabetes. findings from this study will help determine if, and how, the current approach to disseminating the cda dietary recommendations pertaining to gi concept could be improved for better uptake using the most efficient and cost effective patient-centered approaches to nutrition self-management. besides, evidence generated will contribute to addressing some of the controversies regarding the clinical usefulness of the gi concept.

Eligibility criteria:
inclusion criteria: * individuals 18 years of age or older; identified as having t2dm and currently enrolled in the alberta's caring for diabetes cohort study * able to read, understand, and converse in english * willing to provide informed consent and currently living in edmonton. exclusion criteria: * those taking exogenous insulin and having physiological and /or medical conditions that interfere with normal digestive functions.

Keywords: glycemic index dietary intakes
horizontal ridge reconstruction of atrophic anterior maxillary ridges using customized xenograft bone shell with 1 :1 mixture of autogenous and xenograft bone particulate

Conditions: Atrophic Anterior Maxillary Ridges

Summary: using customized xenograft bone shell with mixture of autogenous and xenograft particulate in modified cortical shell technique. by 3d printed model from the ct scans segmentation by special software

using customized xenograft bone shell by 3d printed model from the ct scans segmentation by special software ( mimics ) . all surgeries were performed by the same surgeon . all surgical procedures were performed under strict aseptic conditions, all patients received infiltration local anesthesia (articaine 4% 1:100 000 epinephrine). a midcrestal incision was made in the anterior region using no. 15 blade. a full thickness mucoperiosteal flap was raised to expose the underlying alveolar ridge. the residual remaining bone in the area was minimal, with a maximum measured ridge thickness of 3 or 4 mm. 'to reconstruct the lost alveolar bone, an xenograft bone shell approximately 1 to 2 mm thick was shaped, after 3d print the bone shell were fixed to the buccal defect, using screws . 'the space between the plate and the existing palatal bone wall was then filled using a combination of autograft bone chips and xenograft bone particles . periosteal releasing incision is done to obtain stress free primary closure. the flap will then be closed using interrupted 4/0 resorbable sutures. after 4 month will insert implant . after 3 month will insert final restoration which will be mostly pmf .

Eligibility criteria:
inclusion criteria: * patients with atrophic anterior maxillary ridges exclusion criteria: * heavy smokers * uncontrolled diabetic patients. * pregnant patients. psychiatric patient * pathology related to bone.
emotion: examining affective mechanisms in physical activity engagement

Conditions: Physical Inactivity; Overweight or Obesity; Cancer

Summary: this early-phase trial will test intervention strategies to influence affective mechanisms underlying physical activity and determine whether changes in those mechanisms result in change in physical activity behavior among inactive adults who are overweight or obese.

this orbit model phase 1 trial will examine whether affective mechanisms (1) can be experimentally manipulated in real-world settings; and (2) mediate the relationship between interventions and physical activity behavior. a novel physical activity intervention will be optimized by efficiently disentangling the effects of its core component and two enhancement components on affective mechanisms associated with physical activity engagement.

Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years 2. reside in the united states 3. self-reported bmi ≥ 25 4. current structured physical activity engagement \< 60 minutes per week 5. own a personal smartphone device 6. reside in an area with internet or wi-fi connectivity during the study period 7. able to speak and read in english 8. interested and willing to start a physical activity program 9. willing to wear a fitbit versa smartwatch provided by the study team everyday continuously (including at work and during physical activity), in place of any fitbits or smartwatches previously worn, for the duration of the study period 10. able to read the small font on a smartwatch screen without glasses, or willing to carry reading glasses during physical activity for the purpose of reading the smartwatch screen exclusion criteria: 1. inability to provide informed consent due to cognitive disability 2. inability to engage in one or more key treatment components, including those with medical conditions that preclude physical activity engagement or who cannot wear an accelerometer on the wrist or answer brief surveys on the smartwatch for any reason 3. current pregnancy 4. referred to the study by another participant or from reddit.

Keywords: affective response psychological needs physical activity
the prevent agitation trial ii - children ≤1 year

Conditions: Emergence Delirium

Summary: emergence agitation is a clinical condition in which the child experiences a variety of behavioural disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. emergence agitation is a common challenge in children with a reported incidence of approximately 25% ranging from 10 to 80 %. clonidine is often used off-label in paediatric anaesthesia e.g. sedation in the intensive care unit, prevention of withdrawal symptoms after long-term sedation, as premedication before induction of anaesthesia or as treatment/prevention of emergence agitation. the study is designed as a randomised, placebo-controlled clinical trial evaluating efficacy and safety of a single dose of intraoperative clonidine in children 3-12 months, including pharmacokinetics.


Eligibility criteria:
inclusion criteria: * paediatric patients (male and female), aged 3- ≤ 12 months * scheduled general anaesthesia with sevoflurane and opioid. induction with propofol is optional * the legally acceptable representative for the study participant provides written informed consent/assent for the trial exclusion criteria: * asa \>2 * cardiac, neuro and trauma surgery * ex-premature (\<37 weeks) • premedication with clonidine * intubated prior to scheduled anaesthesia or is expected to require intubation after the procedure * critical illness incl. hemodynamic instability (inotropic drugs needed) * bleeding requiring transfusion prior to scheduled anaesthesia * planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid * malignant disease * cardiac disease incl. arrhythmia * chronic lung disease that may influence study results or study participation in the opinion of the investigator or may comprise safety and well-being of the patient * mental retardation * neurological disease including symptoms similar to emergence agitation * has or is suspected of having a family or personal history of malignant hyperthermia * has or is suspected of having an allergy to study treatment or its excipients * any condition that can in opinion of the investigator, deteriorate safety and well-being of the patients or interfere with pharmacokinetic data * positive covid-19 test or clinical suspicion of covid-19 (according to current local guidelines)

Keywords: anesthesia clonidine sevoflurane pharmacokinetics postoperative nausea and vomiting postoperative pain infant
epidemiological study to identify prognosis and predictive biomarkers for advanced or metastatic renal cell carcinoma

Conditions: Metastatic Renal Cell Carcinoma

Summary: multicentric and prospective epidemiological study (non intervetional) to identify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in metstatic renal cell carcinoma. molecular determinations will be developed ay cima and cnio.

in coming years new tkis for the treatment of mrcc are expected to be available. identificaction of novel biomarkers is required to select those patients who would most benefit from a particular therapeutic strategy: c-met is a tyrosine kinase receptor involved in cellular growth and vascular develoment, also identify as a proto-oncogene. chemiokines: an increase in pro-angiogenic chemokines such as il-6 \& il-8 has been also suggested as a tumor dependent possible mechanism influencing invasion and metastasis after anti-vegf therapy. pbrm1 (baf 180) mutation: second major involved gene in clear cell rcc with truncating mutations in 41% (92/227) of cases. mutations appear to inactive a protein that plays role in remodeling the structure of genetic material.pbrm1 mutations could be (partially) involved in about 40% of clear cell rcc. pbrm1 may affect the processes of cell divsion in renal cells and could consequently be another target for new drugs.

Eligibility criteria:
inclusion criteria: * locally avanced or metastatic renal cell carcinoma with clear-cell component histology candidates to recieve sunitinib or pazopanib in fisrt line under standard clinical practice. * measurable disease by ct or mri * life expectancy \>3 months * written informed consent. * performance status 0-2 exclusion criteria: * any patients who does not fulfill the inclusion criteria.
asian investigation of lanreotide autogel® in the management of gep-nets

Conditions: Neuroendocrine Tumors

Summary: lanreotide autogel® has been established as a standard of care for patients with locally advanced or metastatic gep-nets based on the success of clarinet trial. however, only few patients with asian ethnicity were included in the trial. according to the nationwide comprehensive study of patients with gep-net in korea, hindgut primary nets(rectal) occured more frequently than western countries. however, small intestine or lung primary net is relatively rare compared with western countries.1) considering the clinical characteristics of gep-nets are distinct between the patients in asian and western countries, further evaluation on the efficacy and safety of lanreotide autogel® in asian patients with gep-nets is needed.


Eligibility criteria:
inclusion criteria: * written informed consent * male or female subject aged ≥18 years and legally capable to provide informed consent * functioning or non-functioning gastroenteropancreatic (gep)-neuroendocrine tumor (net) or unknown primary-net * well differentiated tumor * grade (g) 1, g2 according to the 2017 world health organization (who) criteria * subject already treated with lanreotide autogel® for the period up to 5 months, according to local standard of care, prior to documentation into this study * use of lanreotide autogel® monotherapy by local label (smpc). * concomitant locoregional therapy such as surgery, rfa or tae is allowed. exclusion criteria: * parallel participation in an interventional study * lanreotide treatment for more than 5 months prior inclusion into the study * prior anti-proliferative medication with somatostatin analogue (e.g. octreotide lar). * concomitant anti-proliferative systemic medication/therapies for gep-net are not allowed.

Keywords: neuroendocrine tumor somatostatin analogue
a two-week study of the efficacy and safety of mifepristone in the prevention of olanzapine-induced weight gain

Conditions: Weight-Gain Prevention

Summary: this is a two-week study testing the efficacy and safety of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers by measuring changes in body weight and bmi.


Eligibility criteria:
inclusion criteria: * healthy male volunteers between 18 and 40 years of age * bmi between ≥ 18 and ≤ 25 * able to provide written informed consent * routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits exclusion criteria: * history of cushing's syndrome or addison's disease * prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder * positive urine drug screen for any non-prescribed drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines) * participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing * have a history of an allergic reaction to either mifepristone or olanzapine * any clinically significant abnormality on screening laboratory tests * qtc bazzett's ≥ 450 msec * any major medical condition, which in the opinion of the investigator would place the patient at undue risk. * receiving any prescription or over-the-counter medications that could potentially affect appetite or weight * history of recent (within 6 months of screening) significant weight fluctuation